Question 1

What types of medical devices does Darco (Europe) GmbH manufacture?

Accepted Answer

Darco (Europe) GmbH specializes in orthotic devices designed to support and stabilize joints and limbs. Their product line includes prefabricated orthotic insoles for general foot support, non-customized orthotic shoes, and a range of orthoses for the knee, ankle/foot, wrist/hand, elbow, and hip. Examples include knee supports, knee immobilizers, and knee walker braces like the Body Armor® PFA Walker. These devices are intended to aid mobility, reduce strain, or provide temporary support for musculoskeletal conditions.

Question 2

Where is Darco (Europe) GmbH based, and what does that mean for their devices?

Accepted Answer

Darco (Europe) GmbH is headquartered in the United States. This means their devices are subject to U.S. regulatory requirements, including registration in the FDA’s Unique Device Identifier (UDI) database. The company’s location also influences compliance pathways, such as the classification of their products under U.S. regulations, which determines the level of oversight and authorization required for market placement.

Question 3

Which regulatory registries list Darco (Europe) GmbH’s devices?

Accepted Answer

Darco (Europe) GmbH’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying medical devices in the U.S., ensuring traceability and compliance with regulatory requirements. Listing in the UDI database is mandatory for Class I devices, which includes all of Darco’s products, as it helps track their distribution and use in clinical settings.

Question 4

How are Darco (Europe) GmbH’s devices classified under U.S. regulations?

Accepted Answer

All of Darco (Europe) GmbH’s devices fall under Class I classification in the U.S. This classification is assigned to products that pose minimal risk to patients and are generally considered safe with basic regulatory controls. Class I devices require registration with the FDA and compliance with general controls, such as proper labeling and manufacturing practices, but do not typically require pre-market approval or rigorous clinical trials. Examples like their prefabricated insoles and knee supports fit this category due to their low-risk nature.

Device	Model / Reference	Registries	Class	Status
DARCO® Wound Care Shoe System™	WCC4B	FDA UDI	Class I	Unknown
DARCO® PegContour™ Insole Uni	PCIU-ARS1	FDA UDI	Class I	Active
MECRON Knee Straight Clinical L:500mm, OS:540mm, US:330mm	OS500304A	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™	WCS2B	FDA UDI	Class I	Unknown
DARCO® Toe Cap	TCDBW1	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-M1-L	FDA UDI	Class I	Active
DARCO® Relief Contour Insole Left	RC-M2-L	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-ARS0-R	FDA UDI	Class I	Active
MECRON Knee 3-part 10deg	OH655514	FDA UDI	Class I	Active
MECRON Knee Straight L:400mm, OS:430mm, US:300mm	OS400102	FDA UDI	Class I	Active
Body Armor® PFA Walker	BAPFA2	FDA UDI	Class I	Active
DARCO® Posterior Splint Fix	PSF3-110	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-W3H	FDA UDI	Class I	Active
DARCO® Toe Cap	TCO2	FDA UDI	Class I	Unknown
DARCO® PegContour™ Insole	PCI-M2-L	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker Customized	RIW1C-3	FDA UDI	Class I	Active
DARCO® Toe Cap	TCDBM1	FDA UDI	Class I	Active
DARCO® PegContour™ Insole Uni	PCIU-M4	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:600mm, US:350mm	OH600402	FDA UDI	Class I	Active
DARCO® Toe Cap	TCWCS7/L	FDA UDI	Class I	Unknown
DARCO® WCS™ / WCS™ Light Insoles	WCI0/R	FDA UDI	Class I	Active
DARCO® Relief Dual® Plus	RDP-W2	FDA UDI	Class I	Active
DARCO® Body Armor® Heel Reliever	BAHRS-F	FDA UDI	Class I	Active
MECRON Belt B: 29 cm, U: 105-127 cm	38-7440	FDA UDI	Class I	Active
MECRON Belt B: 29 cm, U: 130-157 cm	38-7450	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:490mm, US:280mm	OS500202	FDA UDI	Class I	Active
MECRON Knee Flexion L:400mm, OS:480mm, US:350mm	OH400104S	FDA UDI	Class I	Active
DARCO® Relief Dual®	RD-M1	FDA UDI	Class I	Active
DARCO® Relief Dual® Plus	RDP-M1	FDA UDI	Class I	Active
MECRON Knee Pediatric	OS402001	FDA UDI	Class I	Active
DARCO® OrthoWedge™ Light	OW0B-STL	FDA UDI	Class I	Active
DARCO® Relief Insert™ Walker	RIW-M4-L	FDA UDI	Class I	Active
DARCO® Wound Care Shoe System™	WCC0B	FDA UDI	Class I	Unknown
MECRON Knee Flexion Clinical Sonderanfertigung XXL	OH500504A	FDA UDI	Class I	Active
DARCO® Relief Dual®	RD-BM3	FDA UDI	Class I	Active
MECRON Elbow Splint OA: 250 - 300 mm	OS030100	FDA UDI	Class I	Active
MECRON® ReadyDressment Strips	MRSW500-1	FDA UDI	Class I	Unknown
DARCO® Relief Dual®	RD-M2	FDA UDI	Class I	Active
MECRON Knee Straight L:500mm, OS:590mm, US:380mm	OS500404OS	FDA UDI	Class I	Active
DARCO® Relief Insert™	RI-3	FDA UDI	Class I	Active
DARCO® WCS™ Light	WCSL5-R	FDA UDI	Class I	Unknown
DARCO® PegContour™ Insole	PCI-M4-L	FDA UDI	Class I	Active
DARCO® Body Armor® Heel Reliever	BAHRS-N	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-M2-R	FDA UDI	Class I	Active
DARCO® Body Armor® Sleeve	BAS1	FDA UDI	Class I	Active
DARCO® PegContour™ Insole	PCI-W3-L	FDA UDI	Class I	Active
DARCO® MedSurg Pro	MS-M4H	FDA UDI	Class I	Active
MECRON Knee Flexion L:600mm, OS:500mm, US:270mm	OH600201	FDA UDI	Class I	Active
MECRON Hip-Compression U: 105-125 cm	38-053	FDA UDI	Class I	Active
MECRON Knee Straight L:600mm, OS:500mm, US:270mm	OS600204OS	FDA UDI	Class I	Active

Darco (Europe) GmbH

What Darco (Europe) GmbH makes

Frequently asked questions

Information

Catalogue (615)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)